HCC Surveillance: Comparison of Abbreviated Non-contrast MRI and Ultrasound Surveillance in Cirrhotic Patients With Suboptimal Ultrasound Visualisation

Hepatocellular Carcinoma Clinical Trial

Official title:

HCC Surveillance: Comparison of Abbreviated Non-contrast MRI and Ultrasound Surveillance in Cirrhotic Patients With Suboptimal Ultrasound Visualisation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04455932
• Other study ID #: 2019/PID15472
• Status: Recruiting
• Phase: N/A
• Start date: January 2022
• Est. completion date: March 2027

Study information

• Verified date: September 2021
• Source: Concord Repatriation General Hospital
• Contact: Jessica Yang, MBBS
• Phone: +61297676495
• Email: jessica.yang1[@]health.nsw.gov.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

All international guidelines recommend 6-monthly ultrasound surveillance for patients at risk for liver cancer (hepatocellular carcinoma or HCC), such as patients with cirrhosis. The aim of surveillance is to detect HCC at an early stage when it is still potentially curable. Currently only 4 out of 10 HCCs are detected at the early stage.

Ultrasound surveillance for HCC has a wide ranging sensitivity, dependent on many factors such as operator experience, patient body habitus and liver parenchymal heterogeneity due to chronic liver disease and cirrhosis. In a select group of patients, surveillance ultrasound can be suboptimal or near non-diagnostic.

Currently no guideline offers an alternative surveillance tool for patients who have suboptimal surveillance ultrasounds.

Description:

The investigators plan to conduct a prospective study to examine the diagnostic performance of abbreviated non-contrast MRI (aNC-MRI) versus ultrasound, in a select group of cirrhotic patients with poor ultrasound visualisation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 476
• Est. completion date: March 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion criteria

• Patients with cirrhosis (all causes of cirrhosis, except obscure causes such as vascular or congenital fibrosis) AND reduced visualisation of their liver on ultrasound (vB and vC).

• The criteria of cirrhosis can be obtained with any of the following methods:

1. Histologically by liver biopsy

2. Past signs of decompensated liver disease such as ascites, encephalopathy, varices or bacterial peritonitis

3. Clinically suspicion of cirrhosis PLUS one of the following:

1. Radiological evidence of morphologic changes of the liver and evidence of portal hypertension on US, CT or MRI examinations, including the identification of hepatic surface nodularity, splenomegaly, portal collaterals, varices and ascites

2. Fibroscan (transient elastography) median liver stiffness >12.5 kPa, the Fibroscan must be performed by an experienced technician and interpreted by the hepatologist

3. Platelet count <100 (x10^9/L) with no alternative cause

• Absence of previous history or current suspicion of HCC - Absence of HCC is defined by liver US, multiphase CT or contrast-enhanced MRI within 6 months prior to surveillance

• Patient is able to comply with scheduled visits, evaluation plans and other study procedures in the opinion of the investigator

• Patient is willing to provide written informed consent

Exclusion criteria

• Contraindications to MRI scan (defibrillator, pacemaker, metallic foreign body, severe claustrophobia etc.)

• Contraindications to gadolinium

• Age above 85 years old or younger than 20 years old

• Pregnancy or breast feeding

• Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrolment for the trial or could interfere with the completion of the study

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• HCC
• Hepatocellular Carcinoma

Intervention

Diagnostic Test:
• Abbreviated non-contrast MRI of the liver
every 6 months
• Ultrasound surveillance
every 6 months
• Multiphase contrast-enhanced liver MRI
screening

Locations

Country	Name	City	State
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	St Vincent's Hospital Melbourne	Fitzroy	Victoria
Australia	Gosford Hospital	Gosford	New South Wales
Australia	Austin Hospital	Heidelberg	Victoria
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	Prince of Wales Hospital	Randwick	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
New Zealand	North Shore Hospital	Takapuna	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Concord Repatriation General Hospital

Countries where clinical trial is conducted

Australia,  New Zealand, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCC detection with US surveillance versus aNC-MRI surveillance	The detection of hepatic malignancy on the two modalities will be compared; Sensitivity, specificity, PPV and NPV of HCC detection with US surveillance vs aNC-MRI surveillance; Correlation with diagnostic imaging (multiphase CT or MRI) and/or histopathology as a reference standard; For the diagnosis of HCC we will accept; Imaging diagnosis based on the Liver Imaging Reporting and Data System (LI-RADS); Any pathological proof on biopsy or excision The HCC will then be staged based on the Barcelona clinic liver cancer (BCLC) staging system; For the diagnosis of non-HCC hepatic malignancy we will accept; Imaging diagnosis based on the Liver Imaging Reporting and Data System (LI-RADS); Any pathological proof on biopsy or excision	3 or 5 years

External Links

•   US LIRADS CORE 2017